Determinants of Health-related Quality of Life for Patients After Renal Lithotripsy: PNL Versus RIRS

NCT05851339 | Unknown

• 1 other identifier: SVU/MED/URO016/2.23.4.538
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Percutaneous nephrolithotomy (PNL) and Retrograde intrarenal surgery (RIRS) are well-established procedures for renal stone fragmentation; however, the morbidity, hospitalization, and lost work hours associated with these procedures can negatively affect the health-related quality of life (HRQoL) of the patients \[1-3\]. The choice of modality is based on the European Association of Urology (EAU) and/or American Urological Association (AUA) guidelines. However, selecting a modality is challenging, considering the advantages and drawbacks of both modalities. RIRS while minimally invasive, has an inferior stone-free rate compared with PNL; however, PNL requires general anesthesia and longer hospitalization \[4\]. The need to select the therapeutic modality for urinary lithotripsy based not only on the stone-free rate but also on the subsequent HRQoL of the patient is increasingly recognized \[5\]. The concept of HRQoL is multidimensional, which includes psychosocial, physical, and emotional factors, as well as patient autonomy, and is applicable to a wide variety of medical conditions \[6\]. Patients with urolithiasis represent an ideal group for the investigation of HRQoL, considering the disease's high prevalence, non-life-threatening nature, severe symptoms, and high recurrence rate \[3\]. However, only a few longitudinal studies have investigated HRQoL in patients undergoing lithotripsy for urinary calculi \[7\]. Several studies have evaluated HRQoL using the Short-Form 36-item survey (SF-36) \[3, 7-9\]. Hence, this study aims to compare longitudinal HRQoL between PNL and RIRS at four timepoints: before surgery (Bef), on the day of discharge (0 mo), and 1 month (1 mo) and 6 months (6 mo) after surgical intervention, and to further investigate the factors that may significantly affect the HRQoL of these patients

Conditions

Health Related Quality of Life

Keywords

quality of life , PCNL , RIRS

Outcome Measures

Primary Outcomes (1)

• Determinants of health-related quality of life for patients after renal lithotripsy: PCNL vs RIRS

  estimate quality of life patients after PCNL and after RIRS

  2 years

Study Arms (2)

PCNL

PCNL group applicants will answer SF-36 questionnaire

Other: SF- 36 Questionnaire

RIRS

RIRS group applicants will answer SF-36 questionnaire

Other: SF- 36 Questionnaire

Interventions

SF- 36 Questionnaire OTHER

applicants will fill health related quality of life SF-36 Questionnaire after PCNL or RIRS

PCNL; RIRS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

all patients presented to our clinics will performing PCNL or RIRS 100 patents in each group

You may qualify if:

• all patients performing PNL or RIRS for renal stones 2-4 cm

You may not qualify if:

• Patients refuse to participate in this study Unfit patients Renal Stones more than 4 cm Renal Stones less than 2 cm

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

South Valley University

Qina, Qena Governorate, 831115, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Urology

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: May 9, 2023
• Study Start: January 1, 2021
• Primary Completion: July 15, 2023
• Study Completion: August 1, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)